Yes, and cell therapies have moved very slowly through to approval over the history of cell therapies. People seem to forget this is a cell therapy, and while new rules are being put in place even as we chat, a lot of the frameworks for that are still being framed and innovated at just the regulators.
Even the inspection, you have to think that they needed the right subject matter expert at MHRA to go on that inspection. It’s not like they have a long history of approving cell therapies, so there is going to likely be some care in the entire process of review and approval at every level.
This is not a basic drug/pharmaceutical/chemical. And it is processed in a complex way from the patient, living tissue, and then returned over the course of a few years. That is definitely different than your average drug or even Car-T, which even by itself is still a new area for these regulators as well. But typically I believe Car-T is one big treatment at once.
So they likely kick a lot of tires in their inspection and back and forth and of course we saw that with the HTA license.
News 
Market Data 
Discover 
